Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Depemokimab 100 mg or placebo will be administered subcutaneously once every 26 weeks, for up to 6 doses.
Sponsors
Fujii Masaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or eligible female participants 2. Eosinophilic phenotype measured using Blood Eosinophil Count (BEC) 3. Moderate to severe COPD, defined as - A clinically documented history of COPD for at least 1 year - A post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of less than ()30 percent (%) and = 2 - COPD Assessment Test (CAT) >= 15 - Post-bronchodilator FEV1 =10 pack-years at Screening. 6. Dual (Inhaled corticosteroid (ICS)+ Long-acting beta2-adrenergic receptor agonist [LABA] or LABA+ Long-acting muscarinic receptor antagonist [LAMA]) or triple (ICS+LABA+LAMA) inhaler therapy as assessed by the investigator for at least 3 months 7. Body mass index (BMI) >=16 kilograms per square meter (kg/m^2)
Exclusion criteria
Exclusion criteria: 1. The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of lung disease, and clinical manifestations of lung disease where primary diagnosis is not COPD are excluded - Participants with a current or prior physician diagnosis of asthma - Participants with childhood asthma are permitted, provided that childhood asthma has resolved before 18 years of age and has not recurred 2. COPD severity: Participants with more than one moderate exacerbation or severe exacerbation in the past 12 months prior to Visit 1 3. COPD stability: Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Visit 1 4. Lung resection: Participants with a history of, or plan for lung volume reduction surgery/endobronchial valve procedure 5. Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1 6. Chronic hypercapnia requiring non-invasive positive pressure ventilation (NIPPV) use including Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) are excluded 7. Continuous oxygen: Participants requiring oxygen supplementation for COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate/severe exacerbations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first moderate/severe exacerbation Change from baseline in St. George's respiratory questionnaire (SGRQ) total score (assessed using the SGRQ-C) at Week 52 Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS: COPD) total score at Week 52 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, South Africa, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactMasaki Fujii
PPD-SNBL K.K.
Outcome results
None listed